BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A-MAGNUM FEMORAL HEAD

    MDR report key: 7238559 · Received February 2, 2018

    Report

    Report Number
    0001825034-2018-00450
    Event Type
    Injury
    Date Received
    February 2, 2018
    Date of Event
    January 4, 2018
    Report Date
    February 8, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK042037
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PHOTOGRAPHS AND X-RAYS. THE HEAD SHOWS SOME SCRATCHES AND BLACK DEBRIS. THE CUP SHOWS BONE INGROWTH AND BLACK DEBRIS. RADIOGRAPH REVIEW NOTED, "RIGHT TOTAL HIP ARTHROPLASTY WITH RADIOLUCENCY ALONG THE ACETABULAR CUP SUPEROMEDIALLY AND SUPEROLATERALLY. THERE IS SIGNIFICANT LUCENCY ALONG THE INFERIOR ASPECT OF THE ACETABULAR CUP WITH SURROUNDING SCLEROSIS, POSSIBLE OSTEOLYSIS, AND/OR EVIDENCE OF LOOSENING. FEMORAL COMPONENT IS INTACT. THERE IS HETEROTOPIC OSSIFICATION ALONG THE GREATER TROCHANTER AND THE SUPEROLATERAL ACETABULUM." NO OTHER EVALUATION CAN BE MADE FROM THE PROVIDED PHOTOGRAPHS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    CMP-(B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-00449. CONCOMITANT MEDICAL PRODUCTS: US157858 M2A-MAGNUM PF CUP 58ODX52ID, LOT 406190; 139266 M2A-MAGNUM 52-60 MM TPR INSRT-3, LOT 875170. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED TO ADDRESS THE FORMATION OF BLACK DEBRIS FROM METAL ON METAL ARTICULATION. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79688 M2A-MAGNUM FEMORAL HEAD PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 660200

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R